PARIS - Hyperfine, Inc. (NASDAQ:HYPR), a pioneer in health technology, has announced interim data from a study indicating its Swoop® Portable MR Imaging® system can accelerate the diagnostic process for stroke patients in emergency departments. The findings were presented at the European Society of Neuroradiology (ESNR) Annual Meeting.
The study, part of the ACTION PMR project, compared the portable ultra-low-field Swoop® MRI system's performance to conventional MRI and head CT in acute stroke diagnosis. A standout result was the Swoop® system's median time-to-scan of 2.5 hours, significantly quicker than the 27.7 hours for standard MRI procedures. The system also matched head CT's diagnostic performance and showed good specificity against routine clinical MRI.
Patients reported a positive experience with the Swoop® system, suggesting its potential for broader clinical use. The findings support the system's role in improving the efficiency and accessibility of stroke diagnosis, especially where conventional MRI is not readily available.
Dr. Edmond Knopp, Vice President of Medical Affairs at Hyperfine, expressed satisfaction with the data presented, highlighting the system's potential clinical impact and the positive reception from the European neuroradiology community.
The Swoop® Portable MR Imaging® system is FDA-cleared for brain imaging across all ages and is designed for use where full diagnostic examination is not practical. It provides images that can aid in diagnosis when interpreted by a trained physician. The system is also commercially available in select international markets.
Hyperfine, founded by Dr. Jonathan Rothberg, aims to revolutionize patient care globally with accessible diagnostic imaging. The Swoop® system is part of this vision, offering a portable and transformative solution for brain imaging.
This press release contains forward-looking statements and is based on expectations, estimates, and projections. Actual results may differ materially due to various risks and uncertainties, including those related to product development, market acceptance, regulatory challenges, and the impact of COVID-19 on business operations.
The information provided is based on a press release statement from Hyperfine, Inc.
In other recent news, Hyperfine Inc. reported a record quarter in Q2 2024, with $3.6 million in total revenue, indicating strong growth in both U.S. and international markets. The company's AI-powered software received FDA clearance, paving the way for significant business expansion, particularly with its Swoop system in the Alzheimer's care market. Hyperfine anticipates entering the Alzheimer's market in the second half of 2025.
The company's full-year 2024 revenue is expected to be between $13 million and $16 million, with gross margins of 45% to 50%. However, Hyperfine projects a cash burn of approximately $40 million for 2024. Despite this, the company has a cash runway into early 2026 and is confident in delivering significant business acceleration in 2025 and beyond.
In addition to its domestic growth, Hyperfine is pursuing accreditation and regulatory approvals for international expansion, with a strong pipeline in the U.S., particularly in adult and pediatric hospitals. These are some of the recent developments for the company.
InvestingPro Insights
As Hyperfine, Inc. (NASDAQ:HYPR) continues to make strides in the medical imaging field with its Swoop® Portable MR Imaging® system, the financial metrics and analyst insights from InvestingPro offer a glimpse into the company's current market position. The real-time data indicates a market capitalization of $73.35 million, reflecting the scale of the company within the health technology sector. Despite a challenging P/E ratio of -1.84, suggesting investor caution regarding profitability, the company's revenue growth over the last twelve months stands at a robust 22.01%, signaling a positive reception to its products in the market.
InvestingPro Tips highlight that Hyperfine holds more cash than debt on its balance sheet, which could provide the financial flexibility needed to support ongoing research and development efforts, as well as market expansion. However, analysts have revised their earnings downwards for the upcoming period, and the company is not expected to be profitable this year, which could be a point of consideration for potential investors. It's also worth noting that Hyperfine has experienced a strong return over the last three months, with a 27.03% increase, showcasing recent positive market momentum.
For those interested in further insights, InvestingPro offers additional tips on Hyperfine, which can be accessed through their dedicated page for the company. These insights could provide valuable context for evaluating Hyperfine's potential as it aims to revolutionize patient care with its innovative imaging technology.
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